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Gene-Tailored Acid Reflux Medication for Children with Asthma (GenARA Trial)
GenARA Trial Summary
This trial will see if lansoprazole works better for children with GER and uncontrolled asthma when the dose is based on their CYP2C19 and ABCB1 genes.
GenARA Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowGenARA Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.GenARA Trial Design
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Who is running the clinical trial?
Media Library
- You have had phenylketonuria (PKU) in the past.Children and teenagers between 6 and 17 years old who have been diagnosed with asthma by a doctor.You have been put on a breathing machine for asthma in the past.Your lung function is too low, as measured by a breathing test.You are taking theophylline, azole medications, blood thinners, insulin for Type 1 diabetes, digitalis, or oral iron supplements for iron deficiency within the past month.You spent more than 24 hours in the intensive care unit due to asthma in the past year.You didn't fill out most of the daily diary for your asthma symptoms and medication use during the trial's preparation period.You are taking certain medications that affect CYP2C19 enzymes every day.You have a history of moderate to severe GERD or related disorders that need treatment with acid-blocking medications, according to a specialist.You have been taking a certain kind of medicine for your stomach for a long time.You have been using over-the-counter antacids for heartburn symptoms at least 4 days a week on average for the past month.You had an allergic reaction to lansoprazole or other similar medications, or had a bad reaction to aspartame.You have uncontrolled asthma, which means you may have been using asthma medications frequently, had frequent asthma symptoms at night, visited the emergency room multiple times, or been on a steady dose of inhaled corticosteroid medication for a while.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Group 1: Placebo
- Group 2: Genotype-guided Lansoprazole
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Are there any comparable studies to this one that use lansoprazole?
"The medication lansoprazole was first studied in 2010 at National Taiwan University Hospital. In the decade since, there have been a total of 118 completed clinical trials performed across the world. Currently, there are 7 active trials taking place, with several of these happening in Durham, North carolina."
What is lansoprazole's primary use?
"Lansoprazole, which is available for purchase without a prescription, is most often taken to treat zollinger-ellison syndrome. However, it can also be used as medication for other conditions such as nsaid use and gastric ulcers associated with nsaids or erosive esophagitis."
Are there any preconditions for participating in this research project?
"Researchers conducting this study are looking for children aged 6 to 17 that have been diagnosed with asthma. They hope to enroll a total of 110 patients."
Has the lansoprazole medication been cleared by the FDA for consumer use?
"This medication has been commercially available for some time and, as such, has received a score of 3 on the Power team's safety scale."
Are there any available openings for individuals in this clinical trial?
"That is correct. The clinical trial was posted on 2017-10-31 and is currently recruiting for 110 patients from 2 locations, as indicated by the most recent edit made on 2022-05-25."
Does this experiment test the effects of the medication on elderly patients?
"In order to participate in this trial, patients must be between 6 and 17 years old. Out of the 396 total clinical trials, 132 are for pediatric patients and 264 are for geriatric patients."
How many individuals are included in this clinical trial?
"Yes, this is an ongoing medical trial that was first announced on October 31st, 2017. The most recent update to the study was on May 25th, 2022. They are looking for a total of 110 volunteers from 2 different locations."
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